96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
HB2481

 

Introduced 2/20/2009, by Rep. Tom Cross - Barbara Flynn Currie

 

SYNOPSIS AS INTRODUCED:
 
20 ILCS 2310/2310-640 new

    Amends the Department of Public Health Powers and Duties Law of the Civil Administrative Code of Illinois. Requires the Department of Public Health to develop and implement a neonatal diabetes mellitus registry pilot program. Requires the Department to create an electronic registry to track glycosylated hemoglobin levels of persons with monogenic neonatal diabetes. Requires physicians and other healthcare providers treating a patient with diabetes mellitus with onset before 12 months of age to report the occurrence of all such cases to the Department within 30 days after diagnosis. Requires clinical laboratories performing glycosylated hemoglobin tests for patients with diabetes mellitus with onset before 12 months of age to report the results of each test that the laboratory performs to the Department within 30 days after performing the test. Provides that the Department shall create for dissemination to physicians, healthcare providers, and certain clinical laboratories a consent form. Provides that the physician, healthcare provider, or laboratory shall obtain the informed consent of the patient to the disclosure of the patient's information. Sets forth consent requirements and confidentiality provisions. Provides that the Department shall allow access of the registry to neonatal diabetes mellitus research institutions. Provides that these provisions are repealed on December 31, 2012. Effective immediately.


LRB096 05834 RPM 15914 b

 

 

A BILL FOR

 

HB2481 LRB096 05834 RPM 15914 b

1     AN ACT concerning State government, which may be referred
2 to as Lilly's Law.
 
3     Be it enacted by the People of the State of Illinois,
4 represented in the General Assembly:
 
5     Section 5. The Department of Public Health Powers and
6 Duties Law of the Civil Administrative Code of Illinois is
7 amended by adding Section 2310-640 as follows:
 
8     (20 ILCS 2310/2310-640 new)
9     Sec. 2310-640. Neonatal Diabetes Mellitus Registry Pilot
10 Program.
11     (a) In this Section, "neonatal diabetes mellitus research
12 institution" means an Illinois academic medical research
13 institution that (i) conducts research in the area of diabetes
14 mellitus with onset before 12 months of age and (ii) is
15 functioning in this capacity as of the effective date of this
16 amendatory Act of the 96th General Assembly.
17     (b) The Department, subject to appropriation or other funds
18 made available for this purpose, shall develop and implement a
19 3-year pilot program to create and maintain a monogenic
20 neonatal diabetes mellitus registry. The Department shall
21 create an electronic registry to track the glycosylated
22 hemoglobin level of each person with monogenic neonatal
23 diabetes who has a laboratory test to determine that level

 

 

HB2481 - 2 - LRB096 05834 RPM 15914 b

1 performed by a physician or healthcare provider or at a
2 clinical laboratory in this State. The Department shall
3 facilitate collaborations between participating physicians and
4 other healthcare providers and the Kovler Diabetes Center at
5 the University of Chicago in order to assist participating
6 physicians and other healthcare providers with genetic testing
7 and follow-up care for participating patients.
8     The goals of the registry are as follows:
9         (1) to help identify new and existing patients with
10     neonatal diabetes;
11         (2) to provide a clearinghouse of information for
12     individuals, their families, and doctors about these
13     syndromes;
14         (3) to keep track of patients with these mutations who
15     are being treated with sulfonylurea drugs and their
16     treatment outcomes; and
17         (4) to help identify new genes responsible for
18     diabetes.
19     (c) Physicians and other healthcare providers treating a
20 patient in this State with diabetes mellitus with onset before
21 12 months of age shall report to the Department the following
22 information from all such cases no more than 30 days after
23 diagnosis: the name of the physician, the name of the patient,
24 the birthdate of the patient, the patient's age at the onset of
25 diabetes, the patient's birth weight, the patient's blood sugar
26 level at the onset of diabetes, any family history of diabetes

 

 

HB2481 - 3 - LRB096 05834 RPM 15914 b

1 of any type, and any other pertinent medical history of the
2 patient. Clinical laboratories performing glycosylated
3 hemoglobin tests in this State as of the effective date of this
4 amendatory Act of the 96th General Assembly for patients with
5 diabetes mellitus with onset before 12 months of age must
6 report the results of each test that the laboratory performs to
7 the Department within 30 days after performing such test.
8     (d) The Department shall create for dissemination to
9 physicians, healthcare providers, and clinical laboratories
10 performing glycosylated hemoglobin tests for patients with
11 monogenic neonatal diabetes mellitus a consent form. The
12 physician, healthcare provider, or laboratory shall obtain the
13 informed consent of the patient to the disclosure of the
14 patient's information. At initial consultation, the physician,
15 healthcare provider, or laboratory representative shall
16 provide the patient with a copy of the consent form and orally
17 review the form together with the patient in order to obtain
18 the informed consent of the patient and the physician's, or
19 healthcare provider's, or laboratory's agreement to
20 participate in the pilot program. A copy of the informed
21 consent document, signed and dated by the client and by the
22 physician, healthcare provider, or laboratory representative
23 must be kept in each client's chart. The consent form shall
24 contain the following:
25         (1) an explanation of the pilot program's purpose and
26     protocol;

 

 

HB2481 - 4 - LRB096 05834 RPM 15914 b

1         (2) an explanation of the privacy provisions set forth
2     in subsections (f) and (g) of this Section; and
3         (3) signature lines for the physician, healthcare
4     provider, or laboratory representative and for the patient
5     to indicate in writing their agreement to participate in
6     the pilot program.
7     (e) The Department shall allow access of the registry to
8 neonatal diabetes mellitus research institutions participating
9 in the pilot program. The Department and the participating
10 neonatal diabetes mellitus research institution shall do the
11 following:
12         (1) compile results submitted under subsection (c) of
13     this Section in order to track:
14             (A) the prevalence and incidence of monogenic
15         neonatal diabetes mellitus among people tested in this
16         State;
17             (B) the level of control the patients in each
18         demographic group exert over the monogenic neonatal
19         diabetes mellitus;
20             (C) the trends of new diagnoses of monogenic
21         neonatal diabetes mellitus in this State; and
22             (D) the health care costs associated with diabetes
23         mellitus; and
24         (2) promote discussion and public information programs
25     regarding monogenic neonatal diabetes mellitus.
26     (f) Reports, records, and information obtained under this

 

 

HB2481 - 5 - LRB096 05834 RPM 15914 b

1 Section are confidential, privileged, not subject to
2 disclosure, and not subject to subpoena and may not otherwise
3 be released or made public except as provided by this Section.
4 The reports, records, and information obtained under this
5 Section are for the confidential use of the Department and the
6 participating neonatal diabetes mellitus research institutions
7 and the persons or public or private entities that the
8 Department determine are necessary to carry out the intent of
9 this Section. Medical or epidemiological information may be
10 released as follows:
11         (1) for statistical purposes in a manner that prevents
12     identification of individuals, health care facilities,
13     clinical laboratories, or health care practitioners;
14         (2) with the consent of each person identified in the
15     information; or
16         (3) to promote diabetes mellitus research, including
17     release of information to other diabetes registries and
18     appropriate State and federal agencies, under rules
19     adopted by the Department to ensure confidentiality as
20     required by State and federal laws.
21     (g) An employee of this State or a participating neonatal
22 diabetes mellitus research institution may not testify in a
23 civil, criminal, special, or other proceeding as to the
24 existence or contents of records, reports, or information
25 concerning an individual whose medical records have been used
26 in submitting data required under this Section unless the

 

 

HB2481 - 6 - LRB096 05834 RPM 15914 b

1 individual consents in advance.
2     (h) Not later than December 1, 2012, the Department shall
3 submit a report to the General Assembly regarding the pilot
4 program that includes the following:
5         (1) an evaluation of the effectiveness of the pilot
6     program; and
7         (2) a recommendation to continue, expand, or eliminate
8     the pilot program.
9     (i) The Department shall adopt rules to implement the pilot
10 program, including rules to govern the format and method of
11 collecting glycosylated hemoglobin data, in accordance with
12 the Illinois Administrative Procedure Act.
13     (j) This Section is repealed on December 31, 2012.
 
14     Section 99. Effective date. This Act takes effect upon
15 becoming law.